WASHINGTON, March 9 -- There are two kinds of cell-sorters in David Scadden's lab at the Harvard Stem Cell Institute -- machines that have green tags and machines that don't.
The devices, which cost $500,000 and up, do exactly the same thing. The only difference: if your research is funded by the taxpayers, you can't use a green-tagged machine.
President Barack Obama lifted his predecessor's restrictions on human embryonic stem cell research today, and in doing so, put an end to bizarre rules like this one at Dr. Scadden's lab and others around the country.
The color-coded system ensured that federally-funded scientists didn't accidentally violate former President George W. Bush's 2001 executive order limiting embryonic stem cell research to lines created before Aug. 9 of that year.
But the rule was more than an annoyance: it meant that labs had to spend millions on duplicate equipment. Worse yet, according to Dr. Scadden, it prohibited collaboration and hindered the advancement of science.
So the Harvard researcher says the green tags will go, and scientists nationwide will now have access to billions in funding for embryonic stem cell research with far fewer restrictions.
In a larger sense, the rules were also symbols of the power of religious and political conservatives within the Bush administration. Obama is changing many of these rules -- with a pledge to keep politics out of science.
Along with his executive order, Obama issued a memorandum to guide development of a White House strategy for "restoring scientific integrity to government decision-making."
He said science "is about ensuring that scientific data is never distorted or concealed to serve a political agenda -- and that we make scientific decisions based on facts, not ideology."
New Stem Cell Lines are Needed, Scientists Say
When the Bush administration's rules were established 2001, some scientists thought that as many as 60 embryonic stem cell lines might qualify for continued federal research funding.
But only 21 proved viable over the long term, and they're no longer up to speed with scientists, researchers said.
"The old lines are of decreasing usefulness in the laboratory and they're not very diverse," said Jonathan Moreno, Ph.D., a medical ethicist at the University of Pennsylvania and a senior fellow at the Center for American Progress in Washington.
In addition, the old lines were originally grown on mice cells. That has the potential to introduce foreign agents into the human embryonic cells, and thus into any humans treated clinically with cells developed from them, said Jim Battey, M.D., Ph.D., vice chair of the NIH Stem Cell Task Force.
Scientists now know how to grow human stem cell lines without the animal-cell support, but the original lines remain potentially contaminated.
Critics of embryonic stem cells for research say other types of stem cells -- derived from umbilical cord blood, adult skin cells, or other sources -- can produce the same result without destroying a potential human life.
They point to recent advances made with induced pluripotent stem cells as proof that embryos don't need to be destroyed to further research.
Last week, several groups of scientists reported developing human stem cells from adult skin without the risk of disease associated with viral vectors used in the transformation. (See: Stem Cell Research Takes Another Step Forward and Two Teams 'PiggyBAC' Stem Cell Research)
But despite the new advances, embryonic stem cells are the purest and earliest form of a stem cell, and the "gold standard," said Valina Dawson, Ph.D., co-director of the neuroregeneration program in the Institute for Cell Engineering at Johns Hopkins.
"Theoretically, it's like Play-Doh and you can make whatever you want," said Dr. Dawson.
Douglas Melton, Ph.D., co-director of HSCI -- a leader in developing induced pluripotent stem cells from adult cells -- announced plans to seek federal funding for embryonic stem cell research as soon as the Bush order is lifted.
Researchers like Drs. Dawson and Melton hope the embryonic stem cells hold the key to curing neurological disorders such as Parkinson's and stroke.
While Bush's order has been a barrier for federally-funded scientists, private companies have created new embryonic stem cell lines. But few investors are willing to gamble on a therapy so far away from being ready human patients.
"I'm in the private sector and right now, we're not getting paychecks. It's pretty tough," said Robert Lanza, M.D., chief scientific officer at Advanced Cell Technology, a biotech company in Massachusetts working with stem cell technology.
According to the Coalition for the Advancement of Medical Research (CAMR) privately-funded scientists are "eager to share cell lines with researchers to speed discoveries" but cannot do so if the researcher is being funded by the federal government.
At HSCI, philanthropists have picked up the tab for some of the research that is not eligible for federal funding.
But for institutions less fortunate than HSCI, NIH funding is the only option for embryonic stem cell research, said Dr. Dawson.
More Stem Cell Lines, More Ethical Issues
Obama's executive order won't mean an end to discussion and rules guiding the ethical collection of new embryos, said Amy Comstock Rick, president of CAMR. Far from it.
"You can do a lot of good with this," said John Gearhart, Ph.D., director of the Institute for Regenerative Medicine at the University of Pennsylvania. "And you can perhaps do a lot of bad with this when you think about it."
To ensure the research is carried out properly, NIH will be assigned to develop ethical standards, said Dr. Battey.
At a press briefing later in the day, NIH officials said they would solicit public comment and have guidelines ready within 120 days.
Scientists believe the guidelines are likely to require that all federally-funded research use leftover embryos from in vitro fertilization clinics that would otherwise be destroyed. The guidelines would probably stipulate that the donors couldn't be paid specifically for their embryos, and the research cannot eventually help treat the embryonic donors.
Those guidelines have been introduced in Congress a number of times by Rep. Diana Degette (D-Colo.). Lifting the ban has bipartisan support in Congress, which repeatedly passed bills to loosen the restrictions that President Bush established.
Degette recently re-introduced the guidelines again to prepare for Obama's executive order.
But Congress isn't likely to play a huge role in setting the policy. It's more likely to leave the rule-making to the NIH, said CAMR's Comstock Rick.
Those opposed to research on human embryonic stem cells say ethics guidelines won't make up for the fact that the research is destroying human life.
There are other ways to research stem cells that don't destroy embryos, said Yuval Levin, a former adviser to President Bush on HHS, NIH, and the FDA. Levin was also the chief of staff on the president's council on bioethics.
Now that non-embryonic methods of stem cell research are gaining ground, research won't rely as heavily on embryos as it would have a few years ago, Levin said.
"The change in the politics now will have much less impact than it did four or five years ago," said Levin. "It won't mean as much embryo destruction as it did four or five years ago.
NIH to Fund Three Types of Research
Even with the lifting of the ban, Dr. Battey, the chairman of the NIH Stem Cell Task Force, said he does not expect grant applications to pour in.
The science is just too young, Dr. Battey said.
Comstock Rick disagreed. Scientists are ready for this, she said.
The HSCI has used private funds and solicited excess frozen embryos from patients who chose to donate them to get around the Bush order.
"The lifting of the executive order will allow us to collaborate with people with federal funding, and write joint grant applications with others," said Dr. Melton in a release, outlining the lab's plan to do research on cells and neurons involved in Parkinson's and Alzheimer's disease.
"The removal of this barrier that has stood in our way for eight years will open important new areas of research, and help in moving the field forward more rapidly," Dr. Melton said.
The recently-passed economic stimulus bill contained $10 billion for the NIH. Comstock Rick explained that $8.5 billion could potentially go toward embryonic stem cell research. Of that, some would go toward funding existing grants that scored well, but went unfunded.
The money would also fund two-year grants to supplement existing research, which is where the most immediate promise lies, Comstock Rick said.
Researchers already using embryonic stem cell lines could expand their research away from the "contaminated presidential lines" and toward new, cleaner, more diverse lines, she said.
The third type of grants would be for specific research projects commissioned by NIH -- which worries James Engel, Ph.D., chairman of cell and developmental biology at the University of Michigan Medical School.
Dr. Engel fretted that the NIH-initiated projects would emphasize "new, hurry, trendy" research. He would prefer a focus on approving proposals from outside NIH.
Michigan recently followed the lead of states such as California, New York, and Maryland and passed a referendum recently allowing for the creation of new stem cell lines. The University of Michigan has already begun interviewing researchers and feels it can attract much more talent, Dr. Engel said.
Other researchers agreed that the federal law being overturned will result in U.S. research institutions attracting top talent from around the world.
As more scientists turn to embryonic stem cells, they are hopeful the research will advance in a way that wasn't possible over the past eight years, Dr. Dawson said.
"People have been waiting for this for quite a while so we can get on with our jobs and find ways to cure and treat human disease," Dr. Dawson said. "That's what we have devoted our lives to."
"I'm cautiously optimistic that we'll begin to see breakthroughs using these cells within the next five years," said Dr. Engel.
States may React to Federal Funding Opening Up
While scientists are hoping for the best, they are considering some darker consequences of opening up federal funding for embryonic stem cells. For instance, philanthropists might pull out some funding, which could harm more advanced research since government funding tends to favor basic research, Dr. Scadden said.
At a seminar sponsored by the Center for American Progress, Comstock Rick said she worries that states might pass their own restrictive legislation in response to Obama overturning the order.
Or, states that funded embryonic research might see a flood of new federal dollars as a signal to slash their own funding, said Dr. Dawson. Michigan, California, and several other states that set up their own programs are now suffering huge recession-driven budget strains.
"We've started to make some progress in these states," she said. "If the states pulled back now, it would really stall the forward momentum."
But rather than looking to the unintended consequences, scientists are focused on what they feel is a new science-based era under President Obama.
"I just can't emphasize enough the significance of what I think a new presidency will bring," said Penn's Dr. Gearhart.
Scientists need to engage in policy more than before to prevent lawmakers slapping down restrictions on sound science, said Dr. Gearhart.
"We cannot let this kind of thing happen again. We just can't," said Dr. Gearhart. (See: Clinical Trial of Stem Cells for Spinal Cord Injury Cleared by FDA)